Whey Protein Pre-load and Postprandial Glycemia in Pregnancy

Pregnancy Clinical Trial

— ProGs  

Official title:

Effect of Whey Protein on Postprandial Glucose Excursions in Pregnant Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06170905
• Other study ID #: 78/23
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: University of Ulm
• Contact: Julia Hummel, PhD
• Phone: +49 731 500 44744
• Email: julia.hummel[@]uniklinik-ulm.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This pilot study aims to investigate the intake of whey protein prior to carbohydrate intake as an approach to modulate postprandial glucose excursions during pregnancy.

Description:

Gestational diabetes (GDM) has transgenerational health consequences and increases the risk of type 2 diabetes mellitus in both mother and child. However, there is a lack of practical nutritional concepts for the prevention and treatment of GDM. This randomized controlled pilot study investigates whether the intake of a protein drink before carbohydrate intake lowers postprandial blood glucose levels of pregnant women. Therefore, two 75g oral glucose tolerance tests are performed in 20 pregnant women in a cross-over design, whereby a whey protein solution is drunk 30 minutes before one of the oral glucose tolerance tests (OGTT). If a clinically relevant effect on blood glucose levels is identified, this project can clarify whether the reduction in postprandial glycemia was caused by changes in the secretion of insulin and incretins.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pregnant women between 24+0 and 27+6 (+/- 7 days) weeks of pregnancy after menstruation

• BMI before pregnancy: 18 - 29.9 kg/m2

• No known underlying diseases

• Understanding and voluntary signing of a consent form before study-related examinations

Exclusion Criteria:

• Age < 18 years

• Diabetes mellitus type 1 or type 2

• Drug therapy that raises or lowers blood sugar, e.g. steroids, antidiabetics, insulin.

• Endocrine disorders (e.g. hyperthyroidism, polycystic ovary syndrome (PCOS), ...)

• Current depression or other mental illnesses

• Eating disorder

• Regular intake of medication other than vitamins/trace elements during pregnancy

• Estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73 m²

• C-reactive protein > 10 mg/l

• Transaminase elevation of 2 times the upper norm

• Pre-existing cardiac diseases

• Drug and/or alcohol abuse

• Hb < 12 g/dl

• No consent to be informed about incidentally discovered pathological findings

• Any other (clinical) condition that would endanger participants safety or question scientific success according to the physicians opinion.

Related Conditions & MeSH terms

• Postprandial Glycemia
• Pregnancy

Intervention

Dietary Supplement:
• Whey protein-preload OGTT
Intake of 25 g whey protein diluted in water 30 minutes prior to the start of a regular 75 g oral glucose tolerance test

Locations

Country	Name	City	State
Germany	Universityhospital Ulm	Ulm

Sponsors (1)

Lead Sponsor	Collaborator
University of Ulm

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose course	Course of plasma glucose assessed during a 75 g oral glucose tolerance test with vs without whey protein pre-load in pregnant women.	Timepoint 0-120 minutes during the oral glucose tolerance test.
Primary	Postprandial glucose excursion	Area under the glucose curve (AUC 0-30 Min. and AUC 0-120 Min.) and peak glucose assessed during a 75 g oral glucose tolerance test with vs without whey protein pre-load in pregnant women.	Timepoint 0-120 minutes during the oral glucose tolerance test.
Secondary	Insulin course	Course of insulin assessed during the 75 g oral glucose tolerance test in pregnant women.	Timepoint 0-120 minutes during the oral glucose tolerance test.
Secondary	C-peptide course	Course C-peptide assessed during the 75 g oral glucose tolerance test in pregnant women.	Timepoint 0-120 minutes during the oral glucose tolerance test.
Secondary	Insulin secretion	Insulin secretion assessed during the 75 g oral glucose tolerance test in pregnant women.	Timepoint 0-120 minutes during the oral glucose tolerance test.
Secondary	Insulin sensitivity	Insulin sensitivity assessed during the 75 g oral glucose tolerance test in pregnant women.	Timepoint 0-120 minutes during the oral glucose tolerance test.
Secondary	Glucagon course	Course of glucagon and area under the glucagon curve assessed during the 75 g oral glucose tolerance test in pregnant women.	Timepoint 0-120 minutes during the oral glucose tolerance test.
Secondary	GLP-1 course	Course of glucagon-like peptide 1 (GLP-1) and area under the GLP-1 curve assessed during the 75 g oral glucose tolerance test in pregnant women.	Timepoint 0-120 minutes during the oral glucose tolerance test.
Secondary	GIP course	Course of glucose-dependent insulinotropic polypeptide (GIP) and area under the GIP curve assessed during the 75 g oral glucose tolerance test in pregnant women.	Timepoint 0-120 minutes during the oral glucose tolerance test.
Secondary	Glicentin course	Course of glicentin and area under the glicentin curve assessed during the 75 g oral glucose tolerance test in pregnant women.	Timepoint 0-120 minutes during the oral glucose tolerance test.